Efficacy and Safety of Bifidobacterium Quadruple Live Tablets in Patients With T2DM and Constipation - Trial NCT04982380
Access comprehensive clinical trial information for NCT04982380 through Pure Global AI's free database. This Phase 4 trial is sponsored by Peking Union Medical College Hospital and is currently Not yet recruiting. The study focuses on Type 2 Diabetes Mellitus With Complication. Target enrollment is 120 participants.
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Study Focus
Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live
Interventional
drug
Sponsor & Location
Peking Union Medical College Hospital
Timeline & Enrollment
Phase 4
Jul 31, 2021
Jul 31, 2022
Primary Outcome
Number of bowel movements,Glycosylated hemoglobin,Glycosylated albumin
Summary
Constipation is one of the common complication of diabetes mellitus, whose pathogenesis was
 previously recognized as decreased gastrointestinal motility caused by diabetic autonomic
 neuropathy. It is always treated with gastrointestinal motility drugs or laxatives which may
 have side effects such as gut microbiota dysbiosis and withdraw symptoms. Recently,
 researches have indicated that the risk of developing type 2 diabetes mellitus is associated
 with alterations in the structure of the gut microbiota and have begun to treat diabetic
 constipation by improving gut microbiota of these patients. The rational use of
 microecological preparation for the prevention and treatment of diabetic constipation has
 received increasing attention. This trial is aimed to evaluate the efficacy and safety of
 Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live
 (Siliankang) in the treatment of patients with type 2 diabetes and constipation, and to
 analyze its influence on gut microbiota and blood glucose.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT04982380
Non-Device Trial